Articles

What changes are there in decisions by the Wits Human Research Ethics Committee (Medical) and in process errors by research applicants between 2003 and 2015?

Peter Cleaton-Jones

Abstract

Objective. A retrospective examination of numbers of applications, decision rates, and process errors in 2015 was done for comparison with earlier studies to understand current ethics secretariat workload.

Methods. In December 2015 information from committee minutes of all the meetings (N=11) in 2015 (January - November) was collected to quantify change in application numbers and process errors. Statistical analysis used SAS for Windows (version 9.4). Statistical significance was set at p<0.05.

Results. There were 809 new general research applications considered in 2015. Monthly approvals at first evaluation ranged from 4 to 30% with an overall approval rate of 16%. Minor revision was required in 72%, major revision in 11% and 1% of applications were not approved. The χ2 test for trend for initial approval showed a statistically significant decrease across the study periods (p<0.0001). However, the χ2 test for trend for pending responses from applicants was also statistically significant (χ2=29.64). Informed consent and missing information process errors were the most frequent. There were statistically significant increases in lapses of confidentiality methods (p<0.0001) and discrepancies on application forms (p<0.005).

Conclusion. Applications to the Wits Human Research Ethics Committee (Medical) (HREC (M)) for ethics clearance almost doubled between 2003 and 2015 while approvals at first evaluation approximately halved. This has increased the workload on the HREC (M) secretariat. Process error rates are similar to those in an earlier study except that confidentiality and discrepancies have shown a statistically significant increase. Given limitation on the number of secretariat staff in the current stringent financial circumstances of South African universities, applicants need to improve the quality of their applications to increase approval at first review and reduce secretariat workload